McKesson 26549Recalls & reported problems
Mckesson Medical-Surgical Inc. · SYRINGE/NDL, SAFETY 3CC 25GX5/ · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10612479201115), received between Oct 2, 2020 and Jan 15, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fail-Safe Problem1
- Fluid/Blood Leak1
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2021Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY HAVE HAD TO WASTE DOSES OF VACCINE THIS WEEK DUE TO THE PRODUCT LEAKING EVEN THOUGH THE STAFF WAS VERY DILIGENT IN TIGHTENING THE NEEDLE TO THE SYRINGE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11177364 ↗MalfunctionOct 2, 2020Fail-Safe Problem; Fail-Safe Problem
CUSTOMER REPORTS: NEEDLES SEEM TO BE MORE FLIMSY AND THE SAFETY FEATURE DOES NOT SECURELY LOCK LEAVING PART OF THE NEEDLE EXPOSED, WHICH HAS LED TO NEEDLESTICKS.
Patient problems: Needle Stick/Puncture
MAUDE report 10622956 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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